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Pivotal trial characteristics and types of endpoints used to support Food and Drug Administration rare disease drug approvals between 2013 and 2022.
Clin Trials
January 2025
Rare Diseases Team, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Background/aims: Rare disease drug development faces unique challenges, such as genotypic and phenotypic heterogeneity within small patient populations and a lack of established outcome measures for conditions without previously successful drug development programs. These challenges complicate the process of selecting the appropriate trial endpoints and conducting clinical trials in rare diseases. In this descriptive study, we examined novel drug approvals for non-oncologic rare diseases by the U.
View Article and Find Full Text PDFAdaptive promising zone design for sequential parallel comparison design with continuous outcomes.
Clin Trials
January 2025
Department of Biostatistics, University of Florida, Gainesville, FL, USA.
Introduction: The sequential parallel comparison design has emerged as a valuable tool in clinical trials with high placebo response rates. To further enhance its efficiency and effectiveness, adaptive strategies, such as sample size adjustment and allocation ratio modification can be employed.
Methods: We compared the performance of Jennison and Turnbull's method and the Promising Zone approach for sample size adjustment in a two-phase sequential parallel comparison design study.
Retrospective Analysis of the Correlation between Umbilical Blood Flow Index and Maternal and Fetal Outcomes in Pregnant Women with Gestational Diabetes.
Br J Hosp Med (Lond)
January 2025
Department of Obstetrics and Gynecology, The First Clinical Medical College of Three Gorges University, Yichang Central People's Hospital, Yichang, Hubei, China.
Gestational diabetes mellitus (GDM) is a common complication during pregnancy. This retrospective study investigates the correlation between umbilical blood flow index and maternal-fetal outcomes in pregnant women with GDM, aiming to contribute to evidence-based risk assessment and management strategy in this high-risk obstetric population. This retrospective study recruited 119 pregnant women with GDM who were admitted to the Yichang Central People's Hospital, between January 2022 and January 2024.
View Article and Find Full Text PDFDiagnostic Value of Neutrophil-to-Lymphocyte Ratio (NLR) in Intrahepatic Cholestasis of Pregnancy.
Br J Hosp Med (Lond)
January 2025
Department of Obstetrics, Beilun District People's Hospital, Ningbo, Zhejiang, China.
Intrahepatic cholestasis of pregnancy (ICP) is associated with adverse perinatal outcomes, yet the correlation between ICP and the neutrophil-to-lymphocyte ratio (NLR) remains unclear. This study aims to investigate the diagnostic value of NLR in ICP. In this retrospective case-control study, 113 patients with ICP treated in Beilun District People's Hospital from January 2020 to December 2022 were recruited and categorized as the ICP group, and 209 healthy pregnant women treated during the same period were selected as the control group.
View Article and Find Full Text PDFApplication of the Omaha System-Based Continuous Care Model in Diabetes Health Management for Outpatients within the Framework of "Internet +".
Br J Hosp Med (Lond)
January 2025
Nursing Department, Zhang Ye People's Hospital Affiliated to Hexi University, Zhangye, Gansu, China.
Diabetes is a chronic lifelong condition that requires consistent self-care and daily lifestyle adjustments. Effective disease management involves regular blood glucose monitoring and ongoing nursing support. Inadequate education and poor self-management are key factors contributing to increased mortality among diabetic individuals.
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